Type of Posting: General Announcement
Posting Date: 25–Jul–2014
Expert Committee: General Chapters—Microbiology
A new General Chapter <1223.1> Validation of Alternative Methods to Antibiotic Microbial Assays was proposed in PF 40(4) [Jul.–Aug. 2014]. This proposed General Chapter contains guidelines to demonstrate equivalency between microbial assay procedures and chromatographic procedures. In addition to publishing in Pharmacopeial Forum, USP is providing this notice to further engage stakeholders (e.g., manufacturers, distributors, healthcare providers) to identify and discuss potential impacts of the General Chapter on the pharmaceutical industry.
Microbiological assay methods are used to quantify the potency, or antimicrobial activity, of antibiotics. These microbial assays provide a direct measure of the effectiveness of the antibiotic against a reference microorganism. However, microbial assays have limited selectivity and are not appropriate for evaluating organic impurities. Also, the specific skill sets required for performing microbiological antibiotic assays, their unique equipment requirements, and their comparative complexity deter many stakeholders from using these methods. In contrast, physicochemical analytical procedures, such as high-performance liquid chromatography (HPLC), allow for simpler preparation and analysis of samples and rapid data acquisition with improved precision, accuracy, selectivity, and specificity. Alternative methods can be used effectively for both potency assignment and organic impurity testing. This proposed General Chapter presents points to consider for stakeholders who wish to use physicochemical methods such as HPLC as alternatives to the microbial assay methods described in General Chapter Antibiotics—Microbial Assays <81>.
General Chapter <1223.1> was drafted by an Expert Panel consisting of individuals from industry and from regulatory agencies. The panel operated at the direction of the General Chapters—Microbiology Expert Committee. The Monographs—Small Molecules 1 Expert Committee, which is responsible for the antibiotic monographs in USP–NF, also contributed to the development of the General Chapter.
Interested parties are invited to comment on the proposal. The comment deadline is for this proposal is September 30, 2014. Below is a link to the proposed General Chapter.
Should you have any questions, please contact Ahalya Wise, Senior Scientific Liaison to the General Chapters—Microbiology Expert Committee. (301–816–8161 or aww@usp.org).